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Psychotherapy plus: augmentation of metacognitive therapy with prefrontal transcranial direct current stimulation (tDCS) on depressive symptoms, rumination, and brain waves pattern based on quantitative analysis of the electroencephalogram (QEEG) in individuals with major depressive disorder- sham-controlled randomized double-blind study.

Protocol summary

Study aim
Investigating the effect of transcranial direct current stimulation along with the strengthening of psychotherapy (metacognitive therapy) on depressive symptoms and rumination in people with major depression.
Design
Control group with non-random selection, with 3 experimental groups, double-blind, 60 patients.
Settings and conduct
Patients are examined and interviewed by a psychiatrist. It was performed in Mehr Razavi Clinic in Mashhad
Participants/Inclusion and exclusion criteria
Male and female outpatients with the age range of 20 to 60 years with a diagnosis of depression are used for the study. Entry criteria Not having a history of participating in a metacognitive psychotherapy program; not having a history of epilepsy or convulsions; not having a history of shock therapy (ECT); having a score above 20 in the Beck depression questionnaire; not having acute suicide to participate in treatment sessions; Positive safety screening to perform tDCS. Exit criteria Third, substance abuse or dependence in the past 6 months (excluding nicotine, with current or past nicotine use); Psychotic disorders (lifelong) including schizoaffective disorders or depressive episodes with psychotic symptoms (lifelong); bipolar disorders (types I and II); Neurological disorders, such as stroke in the last 2 years, epileptic attacks (for life), epilepsy, dementia, Parkinson's, Huntington's, multiple sclerosis, as well as any other neurological disease that leads to increased intracranial pressure or increased risk of epileptic seizures; Not having a current risk of suicide, based on the researcher's personal assessment
Intervention groups
Enriched psychotherapy without TDCS, a psychotherapy group enriched with active TDCS, and a psychotherapy group enriched with inactive TDCS and a control group
Main outcome variables
Investigating the effectiveness of treating depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190812044515N1
Registration date: 2023-08-28, 1402/06/06
Registration timing: retrospective

Last update: 2023-08-28, 1402/06/06
Update count: 0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Vahid Farahmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 9096
Email address
v_farahmand_psy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-11, 1401/09/20
Actual recruitment start date
2022-12-01, 1401/09/10
Actual recruitment end date
2022-12-16, 1401/09/25
Trial completion date
empty
Scientific title
Psychotherapy plus: augmentation of metacognitive therapy with prefrontal transcranial direct current stimulation (tDCS) on depressive symptoms, rumination, and brain waves pattern based on quantitative analysis of the electroencephalogram (QEEG) in individuals with major depressive disorder- sham-controlled randomized double-blind study.
Public title
Investigating the effect of Tdcs on metacognitive therapy in the treatment of major depressed people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a history of participating in a metacognitive psychotherapy program. Not having a history of epilepsy or convulsions. Not having a history of shock therapy (ECT). Having a score above 20 in the Beck depression questionnaire. Not having acute suicidality to participate in treatment sessions. Positive safety screening to perform tDCS.
Exclusion criteria:
Substance abuse or dependence in the last 6 months (excluding nicotine, with current or past nicotine use) Psychotic disorders (lifelong) including schizoaffective disorders or depressive episodes with psychotic symptoms (lifelong) Bipolar disorders (types I and II) Neurological disorders, such as stroke in the last 2 years, epileptic attacks (for life), epilepsy, dementia, Parkinson's, Huntington's, multiple sclerosis, as well as any other neurological disease that leads to increased intracranial pressure or increased risk of epileptic seizures Not having a current risk of suicide, based on the researcher's personal assessment
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization to two groups of active tDCS or sham is done in the second step through the random assignment of identifiers by an independent clinical physician who is not involved in the study. To reduce bias during data collection and assessment of clinical endpoints, double-blind tDCS treatment is used. All study personnel, metacognitive therapists, and patients will have no knowledge of whether the active state or sham state will be activated by the tDCS device. Patients are asked not to discuss stimulation with other members of the group.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University - Shahrood branch
Street address
University blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1402.018

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Depression score
Timepoint
Measurement of depression at the beginning of the study and 10 sessions after the intervention and 30 days after the last visit session
Method of measurement
Beck Depression Questionnaire and Nelen Hoeksma Rumination Questionnaire

Secondary outcomes

1

Description
Rumination
Timepoint
At the beginning of the study and the last visit and 30 days after the last visit
Method of measurement
Nelen Hoeksma Rumination Questionnaire

Intervention groups

1

Description
The first intervention group: metacognitive therapy + Active-tDCS, in the above intervention, after the session entered the main part, i.e. the challenge with beliefs, real tDCS with a current whose anode electrode in the posterior-lateral prefrontal cortex of the left DLPC is equivalent to the F3 point in the -20 system. 10EEG and the cathode electrode is on the top of the cingulate cortex on the opposite side, it is activated. And the brand used is ActivaDosII.
Category
Treatment - Devices

2

Description
Intervention group: second intervention group: metacognition therapy + sham-tDCS, in the above intervention, after the session enters the main part, i.e. the challenge with beliefs, tDCS is inactive, in such a way that the location of the electrodes is the same as the anodic stimulation electrodes, with this difference For the initial itching sensation, the current was applied only in the first 30 seconds and then stopped during the test. And the brand used is ActivaDosII.
Category
Treatment - Devices

3

Description
Intervention group: The third intervention group: metacognitive therapy, metacognitive therapy group based on the practical guide of metacognitive treatment of anxiety and depression was implemented for eight sessions of 90-120 minutes among the subjects of the experimental group.
Category
Treatment - Other

4

Description
Control group: They did not receive any intervention during the treatment period, but they were assured that after the end of the research period, therapeutic intervention will be used to help them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Razavi Clinic
Full name of responsible person
Azam Hosseini
Street address
Between Vakil Abad 13 and 15
City
Mashad
Province
Razavi Khorasan
Postal code
9188869547
Phone
+98 51 3603 9545
Email
v_farahmand_psy@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Research assistant
Street address
University street
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3239 4530
Email
info@iau-shahrood.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahnaz Nouhi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
0092332394530
Email
psynut.sh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahnaz Nouhi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University blvd
City
shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3239 4530
Email
psynut.sh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahnaz Nouhi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
002332394530
Email
psynut.sh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Keeping ethical issues in mind, all analyzes are unimpeded
From where data/document is obtainable
To receive data, they can correspond with the following email: v_farahmand_psy@yahoo.com
What processes are involved for a request to access data/document
After sending the request to the mentioned email, according to the volume of the request, the request will be answered between 1 and 7 days
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